Gamp Classification ((better)) «Best · Review»

❌ – Self-learning algorithms break the “configured vs. custom” boundary. A model that retrains post-deployment doesn’t fit Categories 3–5 cleanly.

⭐⭐⭐⭐ (4/5) — Critical for compliance, yet showing its age in parts. 1. What is GAMP Classification? The GAMP (Good Automated Manufacturing Practice) 5 categorization system (from ISPE) classifies computerized system components into Software Categories (1-5) and Hardware Categories (1-2) . The goal: determine the level of validation rigor based on risk and complexity. gamp classification

✅ – Category 4 & 5 explicitly require supplier assessment, pushing companies to audit vendors – a critical but often overlooked step. ❌ – Self-learning algorithms break the “configured vs